Apparatus and method of placement of a graft or graft system

ABSTRACT

A fenestrated graft deployment system, with a delivery catheter having a catheter body, An endoluminal prosthesis having a main graft body, the main graft body having a lumen therethrough and a first opening laterally through a wall of the main graft body. A first guidewire prepositioned within the delivery catheter extending through at least a portion of the catheter body into a main lumen of the endoluminal prosthesis and through the first opening in the wall of the prosthesis when the delivery catheter is in a predeployed configuration. A first fenestration alignment device is configured to extend through at least a portion of the delivery catheter and is configured to be axially moveable relative to the first guidewire. The first fenestration alignment device has an end portion having an outside perimeter configured such that when an end portion of the fenestration alignment device moves toward the first opening of said main graft body the outside perimeter of the first opening is smaller than the outside perimeter of the first fenestration alignment device and prevents it from passing through the first opening and causes the main graft body adjacent to the first opening to move with the end of the first fenestration alignment device to act as alignment tool to allow an operator to align the first opening in the side of the endoluminal prosthesis with an ostium of a target branch vessel into which said first opening is to extend and act as a guide and seal for a subsequently delivered branch graft endoluminal prosthesis.

PRIORITY INFORMATION AND INCORPORATION BY REFERENCE

This application is a divisional of U.S. Application No. 13/287,907,(titled “APPARATUS AND METHOD OF PLACEMENT OF A GRAFT OR GRAFT SYSTEM”),filed Nov. 2, 2011, which claims priority benefit of U.S. ProvisionalApplication No. 61/409,504 (titled “APPARATUS AND METHOD OF PLACEMENT OFA GRAFT OR GRAFT SYSTEM”), filed Nov. 2, 2010, which application ishereby incorporated by reference in its entirety as if fully set forthherein. The benefit of priority is claimed under the appropriate legalbasis including, without limitation, under 35 U.S.C. § 119(e).Additionally, U.S. Pat. Application No. 12/769,506, filed on Apr. 28,2010 (entitled “APPARATUS AND METHOD OF PLACEMENT OF A GRAFT OR GRAFTSYSTEM”) is also hereby incorporated by reference in its entirety as iffully set forth herein.

BACKGROUND OF THE DISCLOSURE Technical Field

Endoluminal vascular prostheses delivery devices and methods ofdeploying such prostheses for use in the treatment of aneurysms atbranches of arterial vessels, in particular the aorta, are described.

Description of the Related Art

An abdominal aortic aneurysm is a sac caused by an abnormal dilation ofthe wall of the aorta, a major artery of the body, as it passes throughthe abdomen.

In certain conditions, the diseased region of the blood vessels canextend across branch vessels. The blood flow into these branch vesselsis critical for the perfusion of the peripheral regions of the body andvital organs. Many arteries branch off the aorta. For example, thecarotid arteries supply blood into the brain, the renal arteries supplyblood into the kidneys, the superior mesenteric artery (“SMA”) suppliesthe pancreas, the hypogastric arteries supply blood to the reproductiveorgans, and the subclavian arteries supply blood to the arms. When theaorta is diseased, the branch vessels may also be affected. Thoracicaortic aneurysms may involve the subclavian and carotid arteries,abdominal aneurysms may involve the SMA, renal and hypogastric arteries.Aortic dissections may involve all branch vessels mentioned above. Whenthis occurs, it may be detrimental to implant a conventional tubulargraft or stent graft in this location of the aorta or the blood vessel,since such a graft may obstruct the flow of blood from the aorta intothe branches.

Prior branch graft arrangements are complex and require many steps ofinsertion and removal to orient and align fenestrations in a main bodyto the surrounding anatomy and still more steps to insert, deploy, andseal a branch graft (covered stent) to the main stent graft body and tothe wall of the branch vessel without unacceptable leakage.

Thus, there is a need to simplify the delivery of branch graft devicesto provide improved reliability and reduced procedure duration.

SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS

Designs and methods of placement of a branch graft or branch graftsystem having lateral openings in the main graft are disclosed. The maingraft is positioned within the main blood vessel such as the aorta sothat the lateral openings (also referred to herein as fenestrations) canbe aligned with the branch blood vessels, to allow blood to flow throughthe openings in the main graft and into the branch vessels. Thepositions of the branch blood vessels can vary from one patient’sanatomy to the next, the graft systems disclosed herein allow a surgeonto adjust the position of the fenestrations in the main body so as toalign them with the branch vessels to improve the efficiency of branchgraft deployment.

The branch graft system can comprise a tubular expandable main body andat least one fenestration or at least one branch graft at any desiredlocation. The main graft body and/or the branch graft can be made froman expandable material, such as but not limited to ePTFE. The main graftcan have two fenestrations or branch grafts formed therein at generallydiametrically opposed locations or at positions that are offset from thediametrically opposed positions. Depending on the particular patient’sanatomy, other cutouts, scallops, or fenestrations, such as but notlimited to a fenestration for the superior mesenteric artery (“SMA”),can be formed in the main graft depending on the patient’s anatomy andposition of the graft.

The main graft body can have a tubular shape and can have a diameterthat can be significantly larger than the diameter of the target vesselinto which the graft is intended to be deployed. As will be described ingreater detail below, the oversized diameter of a portion of the maingraft can provide excess or slack graft material in the main graft toallow the fenestrations to each be moved in one or a combination oflateral, axial and angular directions so that the fenestrations can bealigned with the branch arteries.

One or more branch grafts can be supported by the main graft bodyadjacent to the one or more fenestrations (openings) that can be formedin the main graft body. A compressed branch graft is small enough toallow it to be manipulated into the desired vascular position by movingthe branch graft over a guidewire. The branch graft can be expanded tothe diameter of the branch vessel by mechanical means, which can be adilation balloon, or by the removal of a surrounding restraint in thecase of a self-expanding device.

Some embodiments relate to a fenestrated graft deployment system,comprising a delivery catheter having a catheter body, a prosthesishaving a main graft body, the main graft body having lumen therethroughand a first opening laterally through a wall of the main graft body, afirst guidewire prepositioned within the delivery catheter extendingthrough at least a portion of the catheter body into a main lumen of theendoluminal prosthesis and through the first opening in the wall of theprosthesis when the delivery catheter is in a predeployment state. Thesystem can have a first fenestration alignment device extending throughat least a portion of the delivery catheter configured to be axiallymoveable relative to the first guidewire. The first fenestrationalignment device can be configured such that a portion of thefenestration alignment device contacts the main graft body adjacent tothe first opening to approximately align the first fenestration with anostium of a target branch vessel when advanced relative to thefenestration.

Some embodiments relate to a fenestration push device for use in afenestrated prostheses deployment catheter, comprising a body portiondefining a lumen therethrough, the lumen having a first diameter orcross-sectional size or perimeter, and a protrusion supported at oradjacent to a distal end of the body portion, the protrusion projectingaway from an outside surface of the body portion and defining a secondcross-sectional or perimeter size. The second cross-sectional size ofthe fenestration push device at the location of the protrusion isgreater than the first diameter or size of the body portion.Additionally, the second cross-sectional size of the protrusion isgreater than a cross-sectional size of a fenestration formed in arespective fenestrated graft.

Some embodiments relate to method of deploying a fenestrated endoluminalprosthesis in a patient’s vasculature, comprising advancing a cathetersupporting the endoluminal prosthesis therein through a patient’svasculature to a target vessel location, wherein the prosthesis has amain graft body comprising a first opening through a wall thereof,advancing a first guide sheath through the first opening and into afirst branch vessel, and advancing a first fenestration alignment deviceinto contact with the prosthesis adjacent to the first opening throughthe wall of the prosthesis so as to approximately align the firstopening with an ostium of the first branch vessel.

Some embodiments or arrangements are directed to methods for deployingan endoluminal prosthesis, comprising advancing a catheter supportingthe endoluminal prosthesis therein through a patient’s vasculature to atarget vessel location, advancing one or more catheters through one ormore fenestrations formed in the main graft body and into one or morebranch vessels in the patient’s vasculature, at least partiallyexpanding at least the second portion of the main graft body, andsubstantially aligning the one or more fenestrations formed within thesecond portion of the main graft body with the one or more branchvessels by moving the one or more fenestrations in a circumferentialand/or axial direction toward the ostium of the one or more branchvessels. In any of the embodiments or arrangements disclosed herein, theprosthesis can have a main graft body comprising a first portion, asecond portion, and a third portion. The second portion of the maingraft body has a cross-sectional size that is significantly larger thana cross-sectional size of the first portion and the third portion, andalso significantly larger than a cross-sectional size of the targetvessel.

Some embodiments or arrangements are directed to methods for deploying afenestrated prosthesis in a patient’s blood vessel having at least afirst branch blood vessel, comprising advancing a delivery catheter intoa blood vessel, exposing at least one guide sheath, the guide sheathbeing positioned within the delivery catheter so as to extend from amain lumen of the prosthesis through a first opening formed through awall of the prosthesis, and advancing an angiographic catheter throughthe guide sheath and cannulating a first target branch vessel beforecompletely removing the second restraint. The delivery catheter cansupport the fenestrated prosthesis having a main graft body and at leastone fenestration extending through the main graft body, a firstrestraint restraining a proximal portion of the prosthesis, and a secondrestraint restraining a distal portion of the prosthesis, the distalportion of the prosthesis being closer to a proximal portion of thedelivery catheter than the proximal portion of the prosthesis.

Some embodiments or arrangements are directed to methods for deploying afenestrated prosthesis in a patient’s blood vessel having at least afirst branch blood vessel, comprising advancing a delivery catheter intoa blood vessel, exposing at least one guide sheath, the guide sheathbeing positioned within the delivery catheter so as to extend from amain lumen of the prosthesis through a first opening formed through awall of the prosthesis, and advancing the guide sheath into a firsttarget branch vessel before completely removing the second restraint.The delivery catheter can support the fenestrated prosthesis, and thefenestrated prosthesis can have a main graft body and at least onefenestration therein, a first restraint restraining a proximal portionof the prosthesis, and a second restraint restraining a distal portionof the prosthesis, the distal portion of the prosthesis being closer toa proximal portion of the delivery catheter than the proximal portion ofthe prosthesis,

Some embodiments or arrangements are directed to delivery systems fordeploying an endoluminal prosthesis, comprising a first restraintconfigured to restrain a portion of the prosthesis, a second restraintconfigured to restrain a second portion of the prosthesis, a firstopening through a wall of the prosthesis, a first guide sheath extendingfrom a proximal end of the delivery system into a main lumen of theendoluminal prosthesis and through the first opening in the wall of theprosthesis, a first stent configured to support the first portion of theendoluminal prosthesis, and a second stent configured to support thesecond portion of the endoluminal prosthesis, wherein the guide sheathis moveable before removing the first and second restraints. The firstopening can be positioned between the first and second portions.

Some embodiments or arrangements are directed to endoluminal prosthesescomprising a main graft body defining a flow lumen therethrough, a firstopening passing through a wall of the main graft body, and a firstsupport member supported by the main graft body and overlapping an edgeof the first opening, the first support member being configured toincrease the tear resistance of the main graft body adjacent to thefirst opening.

Some embodiments or arrangements are directed to methods for forming anendoluminal prosthesis having at least one reinforced fenestration in amain portion thereof, comprising forming a graft body having a tubularmain body portion, forming a first opening through a wall of the mainbody portion, the first opening having a first state in which the firstopening is substantially unstretched and a second state in which thefirst opening is stretched so that a size of the first openingincreases, advancing a tubular member partially through the firstopening, and fastening a first end portion and a second end portion ofthe tubular member to the wall of the main body portion adjacent to thefirst opening so that the tubular member completely overlaps an edge ofthe first opening.

Some embodiments or arrangements are directed to methods of deploying anendoluminal prosthesis, comprising advancing a catheter supporting theendoluminal prosthesis therein through a patient’s vasculature to atarget vessel location, advancing one or more catheters through one ormore fenestrations formed in the main graft body and into one or morebranch vessels in the patient’s vasculature, at least partiallyexpanding at least the second portion of the main graft body, andsubstantially aligning the one or more fenestrations formed within thesecond portion of the main graft body with the one or more branchvessels by moving the one or more fenestrations in a circumferentialand/or axial direction toward an ostium of the one or more branchvessels by advancing one or more alignment devices relative to the oneor more fenestrations, engaging such fenestrations with the one or morealignment devices, and aligning such fenestrations with the one or morebranch vessels. The prosthesis can have a main graft body which can havea first portion, a second portion, and a third portion, and the secondportion of the main graft body can have a cross-sectional size that issignificantly larger than a cross-sectional size of the first portionand the third portion, and also significantly larger than across-sectional size of the target vessel.

Some embodiments or arrangements are directed to methods of deploying agraft in a patient’s blood vessel having at least a first branch bloodvessel, comprising advancing a delivery catheter into a blood vessel,the delivery catheter supporting a fenestrated prosthesis comprising amain graft body therein, exposing at least one branch sheath, the branchsheath being positioned within the delivery catheter so as to extendfrom a main lumen of the prosthesis through a first opening formedthrough a wall of the main graft body, advancing an angiographiccatheter into the branch sheath and cannulating a first target branchvessel before expanding the main graft body of the prosthesis, engagingthe main graft body adjacent to the first opening, and advancing themain graft body adjacent to the first opening into approximate alignmentwith an ostium of the target branch blood vessel.

In any of the embodiments disclosed (directly or by incorporation byreference) herein, main graft body, branch grafts, or any othercomponent of the endoluminal prostheses or deployment systems disclosedherein can have at least one radiopaque suture or marker attachedthereto to assist with the placement of such components.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial sectional view of a patient’s vasculatureillustrating an endoluminal prosthesis deployed in the patient’svasculature.

FIG. 2 is a side view of the endoluminal prosthesis illustrated in FIG.1 .

FIG. 3 is a cross-sectional view of the endoluminal prosthesis deployedin the patient’s anatomy, taken at 3-3 in FIG. 1 , before thefenestrations have been aligned with the respective branch vessels.

FIG. 4 is a cross-sectional view of the endoluminal prosthesis deployedin the patient’s anatomy, taken at 3-3 in FIG. 1 , after thefenestrations have been aligned with the respective branch vessels.

FIG. 5A is a side view of a catheter system comprising an introducercatheter and a delivery catheter.

FIG. 5B is an oblique view of a catheter system illustrated in FIG. 5A,showing the outer sheath in a partially retracted position.

FIG. 6 is an oblique view of introducer catheter shown in FIGS. 5A and5B.

FIG. 7 is an exploded view the introducer catheter shown in FIGS. 5A and5B.

FIG. 8 is a close up view the delivery catheter shown in FIGS. 5A and5B.

FIG. 9 is an exploded view the delivery catheter shown in FIG. 5A.

FIG. 10 is a sectional view of a portion 10-10 of delivery cathetershown in FIG. 5A.

FIG. 11A is a sectional view of the delivery catheter shown in FIGS. 5Aand 5B, taken at 11A-11A in FIG. 10 .

FIG. 11B is a sectional view the delivery catheter shown in FIGS. 5A and5B, taken at 11B-11B in FIG. 10 .

FIG. 12 is a side view the catheter system shown in FIG. 5B, showing theouter sheath in a partially retracted position.

FIG. 13 is an close up side view of the portion 13-13 of the cathetersystem shown in FIG. 12 , showing the outer sheath in a partiallyretracted position.

FIG. 14 is an close up side view of the portion 14-14 of the cathetersystem shown in FIG. 12 , showing the outer sheath in a partiallyretracted position and the proximal sheath in a partially advancedposition.

FIG. 15 is a side view the catheter system shown in FIGS. 5A and 5B,showing the outer sheath in a partially retracted position and onebranch sheath and one fenestration alignment component in a partiallyadvanced position.

FIG. 16 is a sectional view of a portion of a patient’s vasculature,showing the delivery catheter of FIG. 5A being advanced through apatient’s abdominal aorta.

FIG. 17 is a sectional view of a portion of a patient’s vasculature,showing the delivery catheter of FIG. 5A and an angiographic catheterbeing advanced through a branch sheath of the delivery catheter toward abranch vessel.

FIG. 18 is a sectional view of a portion of a patient’s vasculature,showing the delivery catheter illustrated in FIG. 5A and the branchsheaths of the delivery catheter being advanced into a patient’s brancharteries.

FIG. 19 is a sectional view of a portion of a patient’s vasculature,showing a distal sheath of the delivery catheter illustrated in FIG. 5Abeing advanced to deploy a proximal portion of the prosthesis.

FIG. 20 is a sectional view of a portion of a patient’s vasculature,showing a peelable sheath of the delivery catheter illustrated in FIG.5A being removed to deploy a distal portion of the prosthesis.

FIG. 21 is a sectional view of a portion of a patient’s vasculature,showing a fenestration alignment component of the delivery catheterillustrated in FIG. 5A advancing an inner wall of the prosthesisadjacent to a fenestration toward an ostium of the target branch vessel.

FIG. 22 is a sectional view of a portion of a patient’s vasculature,showing a branch stent being advanced into the target branch vessel.

FIG. 23 is a sectional view of a portion of a patient’s vasculature,showing the branch stent of FIG. 22 being expanded in the target branchvessel and flared.

FIGS. 24A and 24B are oblique views of a prosthesis having one or morefenestrations therein, the graft being shown in dashed lines in FIG. 24Bfor clarity.

FIG. 25 is a top view of the prosthesis of FIGS. 24 .

FIG. 26 is an enlarged view of a portion of the prosthesis of FIGS. 24 ,defined by curve 26-26 of FIG. 24B.

FIG. 27 is a side view of the stent shown in FIGS. 24 , perpendicular toan axis projecting through the fenestration.

FIG. 28 is a side view of the stent shown in FIGS. 24 , along an axisprojecting through the fenestration.

FIG. 29 is an oblique view of a fenestration alignment component, whichis also referred to herein as a fenestration alignment component.

FIG. 30 is a side view of the fenestration alignment componentillustrated in FIG. 29 .

FIG. 31A is an end view of the fenestration alignment componentillustrated in FIG. 29 .

FIG. 31B is a sectional view through a portion of the fenestrationalignment component, taken at 31B-31B of FIG. 31A.

FIG. 32 is an oblique view of a delivery catheter having thefenestration alignment component of FIG. 29 .

FIG. 33 is an exploded view of the delivery catheter shown in FIG. 32 .

FIG. 34 is a sectional view of a portion of a patient’s vasculature,showing the fenestration alignment component illustrated in FIG. 29advancing an inner wall of the prosthesis adjacent to a fenestrationtoward an ostium of the target branch vessel.

FIG. 35 is a sectional view of a portion of a patient’s vasculature,showing a branch stent being advanced into the target branch vesselwhile the fenestration alignment component illustrated in FIG. 29 can beused to maintain the inner wall of the prosthesis adjacent to afenestration in the prosthesis in the desired position relative to theostium of the target branch vessel.

DETAILED DESCRIPTION

In this description, reference is made to the drawings wherein likeparts are designated with like numerals throughout the description andthe drawings.

Some embodiments described herein are directed to systems, methods, andapparatuses to treat lesions, aneurysms, or other defects in the aorta,including, but not limited to, the thoracic, ascending, and abdominalaorta, to name a few. However, the systems, methods, and apparatuses mayhave application to other vessels or areas of the body, or to otherfields, and such additional applications are intended to form a part ofthis disclosure. For example, it will be appreciated that the systems,methods, and apparatuses may have application to the treatment of bloodvessels in animals.

As will be described, any of the graft embodiments disclosed herein canbe configured to have excess or slack graft material in at least aportion thereof relative to the stent or support member which supportsthe graft. The excess or slack material can result from either anenlarged diametric portion of the graft, excess length of the graftmaterial relative to a stent or other support structure, or acombination of both the enlarged diametric portion of the graft andexcess length of the graft material. The excess graft material can forma bulge or other enlargement in the graft in the approximate location ofone or more fenestrations formed through the graft material. The excessor slack material along the circumference of the graft (in the enlargedportion of the graft) can allow for circumferential and/or axialmovement of the graft material and, hence, can allow for circumferentialand/or axial movement of the one or more fenestrations, relative to thestent and the ostium of the patient’s branch vessels. Therefore, thediameter of the graft at and/or adjacent to the location of one or morefenestrations through the graft material can be larger than the localdiameter of the target vessel. Similarly, the diameter of the graft atand/or adjacent to the location of one or more fenestrations can belarger than the diameter of the non-enlarged portion of the graftmaterial.

For example, any of the embodiments disclosed herein can be configuredsuch that the graft has an enlarged or excess slack portion at oradjacent to the location of the fenestrations, wherein such enlarged orexcess slack portion is free of attachment points or has only a minimalnumber of attachment points to the stent or support structure radiallyadjacent to the enlarged or excess slack portion. In some embodiments,this can result in both freedom of circumferential and axial movement ofthe fenestrations, thereby improving the positional adjustability of thefenestrations. The enlarged or excess slack portions of the graft can beradially unsupported by the stent or support member, or can be supportedby a stent or support member or by connectors connecting support memberspositioned axially adjacent to the enlarged or excess slack portion.Accordingly, any of the graft embodiments described herein can beconfigured to have excess circumferential or longitudinal material atany portion of the graft to increase the positional adjustability of oneor more fenestrations formed in the graft.

Further, any of the graft embodiments disclosed herein, including thosewith diametrically enlarged portions, can have excess graft material inan axial direction. The excess or slack material along the length of thegraft can increase the circumferential and/or axial movement of thegraft material adjacent to the one or more fenestrations formed in thegraft material. Accordingly, the length of the graft material betweenthe proximal and distal attachment points to the stent can be longerthan that of the stent between the proximal and distal attachmentpoints. Or, the graft material in a mid-portion of the graft, includingon either side of the enlarged portion, can have an increased lengthrelative to the stent adjacent to such graft portion.

FIG. 1 is a partial cross sectional view of a patient’s vasculatureillustrating an endoluminal prosthesis deployed in the desired positionwithin the patient’s vasculature.

As an example, FIG. 1 shows an endoluminal prosthesis deployed in apatient’s aorta 10. An aneurysmal sac 10A is also shown. For reference,also illustrated are a patient’s first and second renal arteries 12, 14,respectively, and a patient’s ipsilateral and contralateral iliacarteries 16, 18, respectively. FIG. 2 is a side view of the endoluminalprosthesis 20 illustrated in FIG. 1 . the endoluminal prosthesis 20illustrated in FIGS. 1 and 2 has a main graft body 22, a firstfenestration 24, and a second fenestration 26. The main graft is abifurcated graft having a first bifurcated branch 28 and a secondbifurcated branch 30 for placement in the ipsilateral and contralateraliliac arteries.

The main graft body 22 has a generally cylindrical, tubular shape. Theendoluminal prosthesis 20 can be formed from any suitable material, suchas, but not limited to, ePTFE. The endoluminal prosthesis 20 is formedfrom an expandable material. The endoluminal prosthesis 20 is formedsuch that the main graft body 22 can be sized to be larger than thetarget vessel into which the main graft body 22 is to be deployed. Asillustrated in FIG. 1 , the target vessel can be the aortic artery, andthe endoluminal prosthesis can be deployed so as to span across ananeurysm in the abdominal aortic.

In any of the graft embodiments disclosed herein, the diameter of thegraft body (such as without limitation the main graft body 22) or anenlarged portion of any embodiment of a graft body disclosed herein canbe approximately 30% larger than the diameter of the target vessel orthe diameter of the non-enlarged portion of the graft body. The diameterof the graft body (such as without limitation the main graft body 22) oran enlarged portion of any embodiment of a graft body disclosed hereincan be less than approximately 20%, or from approximately 20% toapproximately 50% or more, or from approximately 25% to approximately40% larger than the target vessel or the diameter of the non-enlargedportion of the graft body, or to or from any values within these ranges.

Further, in any of the graft embodiments disclosed herein, at least aportion of the graft material adjacent to the one or more fenestrationsor openings can be free to translate in a circumferential or axialdirection relative to the stent that the graft is supported by. Forexample, particular portions such as the end portions of the graftmaterial can be sutured or otherwise fastened to the stent, while amid-portion of the graft having one or more fenestrations therethroughcan be unattached to the stent so that such mid portion can be free totranslate relative to the stent and, hence, permit the adjustability ofthe fenestrations relative to the stent. In this configuration, thefenestrations can be adjusted to align with the ostium of the patient’sbranch vessels.

As one non-limiting example, the diameter of the main graft body 22configured for placement in an approximately 26 mm vessel can beapproximately 34 mm in diameter. Therefore, the diameter of the maingraft body 22 can be approximately 8 mm larger than the diameter of thetarget vessel. The diameter of the main graft body 22 can be betweenapproximately 2 mm and approximately 14 mm, or between approximately 4mm and approximately 12 mm, or between approximately 6 mm andapproximately 10 mm larger than the diameter of the target vessel, or toor from any values within these ranges.

The oversized diameter of the main graft body 22 can provide excess orslack graft material in the main graft body 22 such that thefenestrations 24, 26 can each be moved in an axial, rotational, orangular direction, or a combination thereof to align the fenestrations24, 26 with the branch vessels arteries, as will be described in greaterdetail below.

As described above, two or more fenestrations can be formed in the maingraft body 22 at any desired location. With reference to FIG. 2 , thetwo fenestrations 24, 26 can be formed at generally diametricallyopposed locations. However, any number of fenestrations can be formed inthe main graft body 22 at any desired locations. Additionally, scallopsor cutouts can be formed in the distal end portion or at any suitablelocation in the main graft body 22, the scallops or cutouts beingconfigured to prevent obstruction of other arteries branching off of themain vessel into which the main graft body 22 is to be deployed. Forexample, an additional fenestration 32 can be formed in a distal portionof the main graft body 22. The fenestration 32 can be formed so as toalign with a patient’s SMA

FIG. 3 is a cross-sectional view of the endoluminal prosthesis 20deployed in the patient’s anatomy, taken at 3-3 in FIG. 1 , as it mightappear before the fenestrations 24, 26 have become aligned with therespective branch vessels, for example renal arteries 12, 14. Withreference to FIG. 3 , the main graft body 22 (which can be oversized)has been deployed in the target vessel. After the main graft body 22 hasbeen deployed in the target vessel, because the main graft body 22 canhave a larger diameter than the vessel diameter, folds, wrinkles, orother undulations (collectively referred to as folds) 34 can form in themain graft body 22 about the circumference of the main graft body 22.The folds 34 can form in the main graft body 22 as a result of the factthat there can be excess or slack material in the main graft body 22after the main graft body 22 has been deployed in the target vessel.

At least a portion of the main graft body 22 can have undulations,folds, bends, corrugations, or other similar features in the axialdirection therein when the main graft body 22 is in a relaxed state(i.e., before the graft has been deployed). A middle portion of thegraft can have undulations, folds, bends, corrugations or other similarfeatures while the distal or upstream portion defines a smooth contour

FIG. 4 is a cross-sectional view of the endoluminal prosthesis 20deployed in the patient’s anatomy, taken at 3-3 in FIG. 1 , after thefenestrations 24, 26 have become aligned with the respective branchvessels. With reference to FIG. 4 , the oversized main graft body 22 isaligned with the patient’s anatomy by the fenestration 24 following aangiographic or guide catheter over which it is threaded to align withthe respective branch vessel as the main body is deployed, but after thebranch vessel guidewires are positioned in the branch vessels. Forexample, the fenestration 24 as it moves closer to the fenestration 26,causes a gathering of slack material or folds 34 in a first portion 22 aof the main graft body 22 and partially or fully removing the slackmaterial or folds from a second portion 22 b of the main graft body 22.

After the main graft body 22 has been positioned within the patient’sanatomy such that the fenestrations 24, 26 have been aligned with therespective branch vessels, a covered stent, a bare wire stent, or anyother suitable stent or anchoring device can be deployed within the maingraft to secure the graft in the desired location (not illustrated). Abare metal stent deployed within the main graft body 22 can compress thefolds 34 that are formed in the main graft body 22, if any, against thewall of the vessel and secure the main graft body 22 and thefenestrations 24, 26 in the desired locations.

Alternatively, a supra renal stent can be deployed at a distal or upperportion of the main graft body to secure the distal or upper portion ofthe main graft body in the desired location within the patient’svasculature, and one or more axial springs can be anchored to the maingraft body to provide axial or column strength to the main graft body.The springs can have a helical shape, as illustrated, and can have anysuitable size, length, pitch, or diameter. However, such helical shapeis not required. The springs can have any suitable shape, including astraight, flat, round, or non-round shape. The springs can be formedfrom any suitable biocompatible material, such as without limitationstainless steel, Nitinol, or suitable metallic or polymeric materials.

Additionally, any of the features, components, or details of any of thegraft, stents, or other apparatuses disclosed in U.S. Pat. ApplicationNo. 12/496,446, filed on Jul. 1, 2009, entitled CATHETER SYSTEM ANDMETHODS OF USING SAME, U.S. Pat. Application No. 12/390,346, filed onFeb. 20, 2009, entitled DESIGN AND METHOD OF PLACEMENT OF A GRAFT ORGRAFT SYSTEM, U.S. Pat. Application No. 12/101,863, filed on Apr. 11,2008, entitled BIFURCATED GRAFT DEPLOYMENT SYSTEMS AND METHODS, and U.S.Provisional Application 61/409,504, entitled APPARATUS AND METHOD OFPLACEMENT OF A GRAFT OR GRAFT SYSTEM, filed Nov. 2, 2010, can be used,with or without modification, in place of or in combination with any ofthe features or details of any of the grafts, stents, prostheses, orother components or apparatuses disclosed herein. Similarly, any of thefeatures, components, or details of the delivery apparatuses anddeployment methods disclosed in U.S. Pat. Application Nos. 12/496,446,12/390,346, and 12/101,863, can be used, with or without modification,to deploy any of grafts, stents, or other apparatuses disclosed herein,or in combination with any of the components or features of thedeployment systems disclosed herein. The complete disclosures of U.S.Pat. Application Nos. 12/496,446, 12/390,346, and 12/101,863 are herebyincorporated by reference as if set forth fully herein.

FIG. 5A is a side view of a catheter system 1000 comprising anintroducer catheter 1002 (also referred to as an introducer) and adelivery catheter 1004. The delivery catheter 1004 can be configured forthe delivery of an endoluminal prosthesis, including without limitationany endoluminal prosthesis embodiment disclosed herein or any othersuitable prosthesis, or for any other suitable use.

FIG. 5B is an oblique view of a catheter system 1000 illustrated in FIG.5A, showing an outer sheath 1006 of the delivery catheter 1004 in apartially retracted position. With reference to FIGS. 5A and 5B, theouter sheath 1006 can be used to constrain at least a portion of aprosthesis 1010. The prosthesis 1010 can have any of the same features,components, or other details of any of the other prosthesis embodimentsdisclosed herein, including without limitation the embodiments of theprosthesis 1200 described below. The prosthesis 1010 can have any numberof stents or other support members, connectors, grafts, cuts,fenestrations, or other suitable components or features. As used herein,when referring to the prosthesis 1010, distal refers to the end of theprosthesis that is further from the patient’s heart, and proximal refersto the end of the prosthesis that is closer to the patient’s heart. Asused herein with regard to the embodiments of the catheter system 1000,the term distal refers to the end of the catheter system that is furtherfrom the surgeon or medical practitioner using the catheter system, andthe term proximal refers to the end of the catheter system that iscloser to the surgeon or medical practitioner.

As illustrated in FIG. 5B, a distal sheath 1012 (also referred to hereinas a first restraint or first restraining means) can be used toconstrain a proximal portion of the stent graft 1010. The distal sheath1012 can be supported by (connected to) a distal tip 1014 of thecatheter system 1000. The distal tip 1014 can comprise an atraumaticmaterial and design. As will be described in greater detail below, thedistal tip 1014 and, hence, the distal sheath 1012 can be attached to aninner tube 1016 to control the position of the distal tip 1014 and thedistal sheath 1012 relative to an inner core 1020 of the deliverycatheter 1004. The inner core 1020 can be rotatable relative to theouter sheath 1006 so that a prosthesis supported by the deliverycatheter 1004 can be rotated during deployment. The inner tube 1016 canbe slidably positioned coaxially within a lumen in an outer tube 1018that can connect a support member 1022 to the inner core 1020. The outertube 1018 can be connected to an opening or partial lumen 1019 in theinner core 1020 so as to be axially and rotationally fixed to the innercore 1020.

In this configuration, the catheter system 1000 can be configured suchthat advancing the inner tube 1016 relative to an inner core 1020 of thedelivery catheter 1004 causes the distal sheath 1012 to advance relativeto the prosthesis 1010, causing the proximal portion of the prosthesis1010 to be deployed. The prosthesis 1010 (or any other prosthesisdisclosed herein) can be at least partially self-expanding such that, asthe tubular distal sheath 1012 is advanced relative to the prosthesis1010, a proximal portion of the prosthesis 1010 expands against a vesselwall. In some embodiments, only some segments or portions of theprosthesis 1010 such as, portions of the prosthesis axially adjacent toenlarged graft portions of the prosthesis, can be configured to beself-expanding.

The inner core 1020 can be slidably received within the outer sheath1006 of the delivery catheter 1004. As in the illustrated embodiment,the outer sheath 1006 of the delivery catheter 1004 can be longer thanan introducer sheath 1008 of the introducer catheter 1002. Further, aclip 1007 can be supported by the outer sheath 1006 to limit the rangeof axial movement of the outer sheath 1006 relative to the introducercatheter 1002.

Although not required, a core assembly 1021 can be connected to aproximal end portion of the inner core 1020, the core assembly 1021having a reduced cross-sectional profile so as to permit one or moresheath members, fenestration alignment components (also referred toherein as fenestration alignment components), or other tubular or othercomponents to pass through the main body of the delivery catheter 1004and be advanced into one or more lumen within the inner core 1020. Theinner core 1020 can be configured to accommodate the insertion of suchsheath members, fenestration alignment components, or other tubularcomponents into the lumen of the inner core 1020.

In the illustrated embodiment, a proximal end portion of the coreassembly 1021 can comprise a handle member 1023 that is positionedoutside a proximal end portion of the delivery catheter 1004 so as to beaccessible by a user. The handle member 1023 can be configured to permita user to axially or rotationally adjust the position of the inner core1020 relative to the outer sheath 1006.

As discussed above, the inner core 1020, or components axially connectedto the inner core 1020 such as the core assembly 1021, can extendproximally past the proximal end portion 1004 a of the delivery cathetersystem 1004 so that a user can adjust and/or change the axial and/orradial position of the inner core 1020 and, hence, the prosthesis 1010,relative to the outer sheath 1006. Similarly, the inner tube 1016 canextend proximally past the proximal end portion 1004 a of the deliverycatheter 1004 and a proximal end portion 1021 a of the core assembly1021 so that a user can adjust and change the position of the inner tube1016 relative to the inner core 1020.

In the partially retracted position of the outer sheath 1006 illustratedin FIG. 5B, at least a portion of the prosthesis 1010 supported by thecatheter system 1000 can be exposed and, potentially, deployed. A distalportion of the prosthesis 1010 can be exposed and deployed by retractingthe outer sheath 1006 relative to the inner core 1020 or distallyadvancing the inner core 1020 relative to the outer sheath 1006, causingat least a portion of the distal portion of the prosthesis 1010 toself-expand. As will be described, the prosthesis 1010 can be configuredto have radially self-expanding support members therein along only aportion or portions of the prosthesis 1010. For example, a graft of theprosthesis 1010 can be radially unsupported at or adjacent tofenestrations formed in the graft. Alternatively, at least the distalportion of the prosthesis 1010 can be constrained within a sheath, suchas a peelable sheath. Embodiments of the sheath will be described ingreater detail below.

The delivery catheter 1004 can also have one or more branch or guidesheaths 1024 supported thereby. The delivery catheter 1004 can havethree or more branch sheaths 1024. Such a configuration can be used fordeploying branch stents into one or more branch vessels in the thoracicaorta. Each of the one or more branch sheaths 1024 can be configured tobe slidably supported within one or more lumen 1025 formed in the innercore 1020 so that each of the one or more branch sheaths 1024 can beaxially advanced or retracted relative to the inner core 1020. Further,the delivery catheter 1004 can be configured such that the branchsheaths 1024 can be rotationally adjusted or twisted relative to theinner core 1020. In some embodiments, each branch sheath 1024 can bepositioned within the delivery catheter 1004 such that, in the loadedconfiguration wherein a prosthesis 1010 is supported (compressed) withinthe delivery catheter 1004, each branch sheath 1024 is pre-positioned soas to be advanced through a fenestration or branch graft of theprosthesis 1010. Each branch sheath 1024 can be positioned within thedelivery catheter 1004 such that a distal end portion of each branchsheath 1024 projects past an end portion of the inner core 1020 and isconstrained within the outer sheath 1006. As illustrated in FIGS. 5A-5B,in this configuration, the distal end portion of each branch sheath 1024can be exposed by retracting the outer sheath 1006 relative to the innercore 1020 and/or the branch sheaths 1024.

Additionally, with reference to FIG. 5B, although not required, thedelivery catheter 1004 can have one or more fenestration alignmentcomponents 1026 supported thereby. The one or more fenestrationalignment components 1026 can be slidably received within one or morelumen 1027 formed in the inner core 1020. The one or more fenestrationalignment components 1026 can each have an end portion 1026 a that canbe sized and configured to surround an outer surface of each of thebranch sheaths 1024. The end portion 1026 a of each fenestrationalignment component 1026 can have, an open or closed annular or circularshape and can be of sufficient size and stiffness to permit a user toengage a fenestration or branch graft formed in or supported by a mainbody of the prosthesis 1010. For example, as will be described ingreater detail below, after the main body of the prosthesis 1010 hasbeen released from the outer sheath 1006 and any other radialrestraints, a user can independently or collectively axially advance thefenestration alignment component 1026 over the branch sheaths 1024 suchthat the end portion 1026 a of each fenestration alignment component1026 contacts the edge or surface adjacent to and surrounding thefenestration or branch graft of the prosthesis 1010 and pushes thefenestration or branch graft toward an ostium of the target branchvessel of the patient’s vasculature.

Accordingly, in this configuration, at least a portion of each of theone or more fenestration alignment components 1026 is configured to beslidably supported within a lumen formed in the inner core 1020 so thateach of the one or more fenestration alignment components 1026 can beaxially advanced relative to the inner core 1020. Further, the deliverycatheter 1004 can be configured such that the fenestration alignmentcomponents 1026 can be axially or rotationally adjusted or twistedrelative to the inner core 1020, for increased maneuverability of thefenestration alignment components 1026.

In some embodiments, each fenestration alignment component 1026 can bepositioned within the delivery catheter 1004 such that, in the loadedconfiguration wherein a prosthesis 1010 is supported (compressed) withinthe delivery catheter 1004, each fenestration alignment component 1026is pre-positioned so that the end portion 1026 a of each fenestrationalignment component 1026 is positioned distal to the end portion of theinner core 1020. In the loaded configuration, each fenestrationalignment component 1026 can be positioned such that the end portion1026 a of each fenestration alignment component 1026 is located withinthe main lumen of the main body of the prosthesis 1010.

The branch sheaths 1024 and fenestration alignment components 1026 canhave any suitable size and can be made from any suitable material. Forexample, the branch sheaths 1024 can have an approximately 6.5 Frenchdiameter, or from an approximately 5 Fr diameter or less to anapproximately 8 Fr diameter or more, or to or from any values withinthis range. The fenestration alignment components 1026 can be formedfrom stainless steel, Nitinol, or any other suitable metallic ornon-metallic material, and can have a thickness suitable to prevent thefenestration alignment components 1026 from buckling when axiallyadvanced against a portion of the prosthesis 1010. For example, thefenestration alignment components 1026 can have an approximately 1 Frdiameter, or between approximately a 1 Fr and approximately a 4 Frdiameter. Further, the fenestration alignment component or catheters canbe formed from a 0.035 in guidewire or otherwise have a 0.035 indiameter.

Additionally, as will be described below in greater detail, the cathetersystem 1000 can be configured such that the distal sheath 1012 can beadvanced relative to the inner core 1020 and the prosthesis 1010, toexpose a proximal portion of the prosthesis 1010. In particular,advancing the distal sheath 1012 can be accomplished by advancing theinner tube 1016 connected to the distal tip 1014 and the distal sheath1012, so that the distal sheath 1012 releases the proximal portion ofthe prosthesis 1010. Other details regarding the distal sheath 1012 ormethods of using the distal sheath can be found in U.S. Pat. No.6,953,475, which application is incorporated by reference as if fullyset forth herein.

FIGS. 6 and 7 are oblique and exploded views, respectively, of theintroducer catheter 1002 shown in FIG. 5A. The introducer catheter 1002can have any of the features or components of any of the embodimentsdisclosed in U.S. Pat. Application No. 12/496,446, which disclosure ishereby incorporated by reference as if set forth herein. With referenceto FIGS. 6-7 , the introducer 1002 can have a main body 1030, athreadably engageable hub portion 1032, a threaded cap 1034 configuredto threadably engage with a threaded distal end portion 1030 a of themain body 1030 so as to secure the outer sheath 1006 to the main body1030. The outer sheath 1006 can have a flanged end portion 1036 securedthereto or integrally formed therewith. The main body 1030 can support aseal assembly 1040 therein to seal around the inner core 1020 of thedelivery catheter 1004 and/or other components of the catheter system1000. A threaded end member 1042 having a threaded proximal end portion1042 a can be supported by the main body 1030. An annular seal member1046 can be supported by the main body 1030 of the introducer catheter1002. The introducer catheter 1002 can be configured such that the sealmember 1046 can be adjusted to provide an additional seal around theinner core 1020 of the delivery catheter 1004 by threadably engaging thehub portion 1032. The seal assembly 1040 and seal member 1046 can haveany of the details, features, or components of any of the embodiments ofthe introducer catheter described in U.S. Pat. Application No.12/496,446, which application is incorporated by reference as if fullyset forth herein.

A tube assembly 1048 can be supported by the main body 1030 of theintroducer catheter 1002 so as to provide an orifice or access port intothe main body 1030. The tube assembly 1048 can be used to flush theintroducer catheter 1002 with saline or other suitable substances at anystage, such as but not limited to prior to the advancement of anendoluminal prosthesis through the introducer catheter 1002 and/ordelivery catheter 1004, or prior to other procedures for which anothertype of delivery catheter may be used. The tube assembly 1048 cansupport any suitable medical connector and/or valve on the distal endthereof.

FIGS. 8 and 9 are oblique and exploded views, respectively of thedelivery catheter 1004 shown in FIG. 5A. FIG. 10 is a sectional view ofa portion 10-10 of the delivery catheter 1004 shown in FIG. 5A. FIG. 11Ais a sectional view of the delivery catheter 1004 shown in FIG. 5A,taken at 11A-11A shown in FIG. 10 . FIG. 11B is a sectional view of thedelivery catheter 1004 shown in FIG. 5A, taken at 11B-11B shown in FIG.10 .

As shown therein, the delivery catheter 1004 can have a main body 1050that can support the inner core 1020 and/or core assembly 1021, one ormore access ports 1052 for the one or more branch sheaths 1024, and oneor more access ports 1054 for the one or more fenestration alignmentcomponents 1026. The access ports 1052, 1054 can be configured tosealingly tighten around the branch sheaths 1024 or the fenestrationalignment components 1026, and to constrict around the branch sheaths1024 or the fenestration alignment components 1026 so as tosubstantially axially secure the branch sheaths 1024 or the fenestrationalignment components 1026. A sealable cap assembly 1051 can bethreadably engaged with the main body 1050 of the delivery catheter1004. The cap assembly 1051 can be configured such that, when a usertightens the cap assembly 1051 relative to the main body 1050 of thedelivery catheter 1004, the core assembly 1021 and/or inner core 1020will be axially and/or rotational secured to the main body 1050 of thedelivery catheter 1004.

A tube assembly 1059 can be supported by the main body 1050 of thedelivery catheter 1004 so as to provide an orifice or access port intothe main body 1050. The tube assembly 1059 can be used to flush thedelivery catheter 1004 with saline or other suitable substances. Thetube assembly 1059 can support any suitable medical connector and/orvalve on the distal end thereof.

As mentioned above, the support member 1022 can be connected to a distalend portion of the outer tube 1018 so as to be axially engaged by theouter tube 1018. The support member 1022 can have a substantiallycylindrical shape and can be sized to fit within the inner lumen of amain body of the prosthesis 1010 when the prosthesis 1010 is in aconstrained configuration. As will be described, in the loadedconfiguration, the prosthesis 1010 can be positioned over the supportmember 1022 so that a proximal portion of a main body of the prosthesis1010 is positioned distally of the support member 1022 and so that adistal portion of a main body of the prosthesis 1010 is positionedproximally of the support member 1022. In this configuration, a proximalend portion 1012 a of the distal sheath 1012 can be positioned over adistal portion 1022 a of the support member 1022, and a distal endportion 1006 a of the outer sheath 1006 over a proximal portion 1022 bof the support member 1022.

In some embodiments, one or more tab members 1074 can be supported bythe outer tube 1018. The one or more tab members 1074 can be configuredto increase the rotational engagement of the constrained prosthesis 1010relative to the outer tube 1018 so that the constrained prosthesis 1010can be rotated with greater accuracy during deployment. The one or moretab members 1074 can have a generally flat, plate-like shape, such as isillustrated in FIG. 8 . The one or more tab members 1074 can be formedfrom a suitable polymeric or metallic material. The one or more tabmembers 1074 can comprise one or more radiopaque features or be formedfrom a radiopaque material to improve the visibility and alignability ofthe delivery catheter 1004 under fluoroscopy during deployment of theprosthesis 1010.

The one or more tab members 1074 can be similar to any of theembodiments of the torsion tab (such as the torsion tab 196) disclosedin U.S. Pat. Application No. 12/101,863, which disclosure isincorporated by reference as if fully set forth herein. The one or moretab members 1074 can be integrally formed with the outer tube 1018, orsecured thereto such as by thermal bonding, adhesive bonding, and/or anyof a variety of other securing techniques known in the art.

As is illustrated, the main body portion of the prosthesis 1010 can beconstrained by a peelable sheath or by the outer sheath 1006 such thatthe prosthesis 1010 is engaged with the one or more tab members 1074.The one or more tabs 1074 can engage a stent or other portion of anendoskeleton of the prosthesis 1010, or, can engage the material of thegraft 1204 surrounding the tab member 1074 so that the prosthesis 1010can substantially rotate with the inner core 1020 of the deploymentcatheter 1004.

FIG. 12 is a side view of the catheter system 1000 showing the outersheath 1006 in a partially retracted position, similar to theconfiguration shown in FIG. 5B. FIG. 13 is an enlarged side view of theportion 13-13 of the catheter system shown in FIG. 12 .

With reference to FIG. 13 , the mid portion of the prosthesis 1010adjacent to the one or more fenestrations 1011 and/or the distal portion1010 a of the prosthesis can be constrained within a peelable sheath1060. The peelable sheath 1060 can have a release wire 1062 threadablyadvanced through a plurality of openings 1064 formed along at least aportion of the sheath 1060. The peelable sheath 1060, release wire 1062,and openings 1064 can have any of the same features, materials, or otherdetails of the similar components disclosed in U.S. Pat. Application No.12/101,863, which application is incorporated by reference as if fullyset forth herein. The release wire 1062 can be slidably received withina lumen in the inner core 1020 so that a user can retract the releasewire 1062 by grasping and retracting a proximal portion of the releasewire 1062 positioned outside the patient’s body.

However, the mid portion of the prosthesis 1010 adjacent to the one ormore fenestrations 1011 and/or the distal portion 1010 a of theprosthesis can be constrained within one or more tubular sheaths, suchas the outer sheath 1006 (also referred to herein as a second restraintor second restraining means) and/or distal sheath 1012 such thatadditional restraining means such as the sheath 1060 are not required(not illustrated). Therefore, any of the embodiments disclosed hereinhaving the optional sheath 1060 should be understood to be configurableto not use the sheath 1060 to restrain one or more portions of theprosthesis 1010. The prosthesis 1010 can be configured such that the midportion of the prosthesis 1010 adjacent to the one or more fenestrations1011 is not radially supported by a stent, connectors, struts, or anyother similar structure such that, when the outer sheath 1006 ispartially retracted, the mid portion of the prosthesis does notself-expand.

The prosthesis 1010 can have one or more openings 1011 formed therein.For example and the fenestrations or openings 1011 can be formed in theprosthesis 1010 at diametrically opposing positions. As will bedescribed in greater detail below, one or more of the openings 1011 canbe formed in the prosthesis 1010 at a position that is angularly offsetfrom the diametrically opposing position. Similarly, when used, thesheath 1060 can have one or more openings 1061 formed therein, theopenings 1061 being positioned adjacent to the similar number ofopenings 1011 formed in the prosthesis. The catheter system 1000 can beconfigured such that the sheaths 1024 are advanced through the openings1011 formed in the prosthesis 1010 and the openings 1061 formed in thesheath 1060, when the prosthesis 1010 is loaded within the cathetersystem 1000.

With reference to FIG. 11B, due to the non-uniform design of the stentwithin the graft material, the prosthesis 1010 can be efficiently packedwithin the outer sheath 1006 so as to surround the sheaths 1024 andefficiently fill the space within the outer sheath 1006. In thisconfiguration, for example, the prosthesis 1010 can be loaded within theouter sheath 1006 so that the sheaths 1024 are advanced between many ofthe struts, bends, loops, and other features that the stent cancomprise, thereby permitting the sheaths 1024 sufficient space to beloaded within the outer sheath 1006 so that the lumen of the sheaths1024 are not compressed or collapsed in the loaded state. Additionally,the graft can be formed from a bidirectionally expanded, layered PTFEmaterial have thin walls to further increase the space efficiency of theprosthesis 1010.

As illustrated in FIG. 13 , where used, the peelable sheath 1060 canhave one or more release wires 1062 (two being shown) advanced throughopenings or perforations 1064 formed in the sheath 1060 along two sidesof the sheath 1060. The release wires 1062 can be configured to tear thesheath 1060 along two lines of perforations 1064 and/or scores formedalong two sides of the sheath 1060, so that the sheath 1060 can beremoved from the prosthesis 1010 while the sheaths 1024 are advancedthrough the fenestrations 1011, 1061, respectively, in the prosthesis1010 and sheath 1060. In this configuration, each of the two releasewires 1062 can be secured to a proximal end portion 1060 a of the sheath1060, so that both halves of the sheath 1060 can be retracted throughthe outer sheath 1006.

However, as illustrated in FIG. 14 , the catheter system 1000 can beconfigured to only have one release wire 1062 threadably advancedthrough the sheath 1060. FIG. 14 is an enlarged side view of thecatheter system 1000 shown in FIG. 5A, defined by curve 14-14 shown inFIG. 12 , showing the outer sheath 1006 in a partially retractedposition and the distal sheath 1012 in a partially advanced position.

The perforations 1064 formed in the sheath 1060 can be arranged along anaxial line along the length of the portion of the sheath 1060 from thefenestrations 1061 to the distal end of the sheath 1060, and alsoarranged to split the sheath 1060 between the two fenestrations 1061formed in the sheath 1060. As illustrated in FIG. 14 , the perforations1064 formed in the sheath 1060 arranged along the length of the sheath1060 can be positioned to tear the sheath 1060 from one of thefenestrations 1061 to the distal end 1060 b of the sheath 1060, and alsoto circumferentially tear the sheath 1060 between the fenestrations1061.

As mentioned above, with reference to FIG. 14 , the catheter system 1000can be configured such that a proximal portion 1010 b of the prosthesis1010 can be deployed by axially advancing the inner tube 1016 relativeto the inner core 1020 of the delivery catheter 1004 and, hence, theprosthesis 1010. The prosthesis 1010 can be self-expanding such thatremoving the radial constraint provided by the distal sheath 1012 cancause the portion of the prosthesis 1010 constrained by the inner tube1016 to expand toward the vessel wall. The proximal portion 1010 b ofthe prosthesis 1010 can be deployed in this manner before the distalportion 1010 a of the prosthesis 1010 is deployed, or simultaneouslywith the deployment of the distal portion 1010 a of the prosthesis 1010.The proximal portion 1010 b of the prosthesis 1010 can be deployed inthis manner after the distal portion 1010 a of the prosthesis 1010 isdeployed.

FIG. 15 is a side view of the catheter system 1000 shown in FIG. 5A,showing the outer sheath 1006 in a partially retracted position and onebranch sheath 1024′ and one fenestration alignment component 1026′ in apartially advanced position. The branch sheath 1024′ can be advancedrelative to the inner core 1020, the prosthesis, and the second branchsheath 1024″ by advancing a proximal portion of the branch sheath 1024′in the direction of arrow A1 in FIG. 15 through the access port 1052′ atthe proximal end of the delivery catheter 1004. Similarly (not shown),the second branch sheath 1024″ can be advanced relative to the innercore 1020, the prosthesis, and the first branch sheath 1024′ byadvancing a proximal portion of the branch sheath 1024″ through theaccess port 1052″ at the proximal end of the delivery catheter 1004.Additionally, either of the fenestration alignment components 1026′,1026″ can be advanced relative to the branch sheaths 1024′, 1024″ byadvancing the respective fenestration alignment component 1026 throughthe respective access port 1054. For example, the fenestration alignmentcomponent 1026′ can be advanced by advancing the proximal portion of thefenestration alignment component 1026′ in the direction of arrow A2 inFIG. 15 .

With the embodiments of the catheter system 1000 having been described,several configurations of deployment methods for an endoluminalprosthesis, including any suitable prosthesis or any endoluminalprosthesis disclosed herein, will now be described with reference toFIGS. 16 - 23 . FIG. 16 is a sectional view of a portion of a patient’svasculature, showing the delivery catheter 1000 being advanced through apatient’s abdominal aorta over a guidewire 1070 positioned within apatient’s vasculature. As in the illustrated embodiment, the deliverycatheter 1000 can be advanced through a prosthesis 1080 (which can be abifurcated prosthesis) deployed within the patient’s vasculature.

FIG. 17 is a sectional view of a portion of a patient’s vasculature,showing the delivery catheter 1000 and an angiographic catheter 1065being advanced through a branch sheath 1024 of the delivery cathetertoward a target branch vessel. As illustrated, an outer sheath 1006 ofthe catheter system 1000 has been retracted relative to the inner core(not shown) and the prosthesis 1010, exposing a middle portion of theprosthesis 1010 (i.e., a portion of the prosthesis 1010 radiallyadjacent to the one or more fenestrations 1011) and the branch sheaths1024 a, 1024 b. After the branch sheaths 1024 a, 1024 b have beenexposed, a suitable angiographic catheter 1065 can be advanced throughthe lumen of either or both of the branch sheaths 1024 a, 1024 b anddirected into the target branch vessel or vessels. A user can rotate theinner core 1020 to approximately rotationally align the fenestrations1011 of the prosthesis 1010 or the branch sheaths 1024 with the branchvessels.

As discussed above, the optional sheath 1060 can constrain the mid anddistal portions of the prosthesis 1010 such that, when the outer sheath1006 is retracted, the mid and distal portions of the prosthesis 1010 donot self-expand. However, the mid portion of the prosthesis 1010radially adjacent to the one or more fenestrations 1011 can beunsupported by any stents 1254. In this configuration, the prosthesis1010 can be configured such that there is no radial force or supportprovided to the mid portion of the prosthesis 1010, or such that the midportion of the prosthesis 1010 will not be biased to self-expand whenthe outer sheath 1006 is retracted. Accordingly, some embodiments can beconfigured such that no additional restraint in addition to, forexample, the outer sheath 1006, is required. Therefore, only the outersheath 1006 and the distal sheath 1012 can be used to restrain theprosthesis 1010. In this configuration, the outer sheath 1006 can bepartially retracted to release the sheaths 1024 so that one or moreangiographic catheters 1065 can be advanced through the sheaths 1024 andinto the target branch vessels before the proximal and distal portionsof the prosthesis 1010 are released from the deployment catheter 1004.

The angiographic catheter 1065 can be configured such that an endportion thereof is biased to have a curved disposition (shape), as iswell known in the art.

As shown, an angiographic catheter 1065 is being advanced relative tothe branch sheath 1024 a and into the target branch vessel, in this casea renal artery. The delivery catheter 1000 can be configured such thatan angiographic catheter can be advanced through the desired branchsheath 1024 and into the target vessel without retracting the outersheath 1006. After the angiographic catheters 1065 have been directedinto the target location, in this case the branch vessels, either orboth of the branch sheaths 1024 can be independently or simultaneouslyadvanced over the angiographic catheters 1065 into the target branchvessels, as is illustrated in FIG. 18 . The branch sheaths 1024, thefenestrations 1011, 1061 formed in either the prosthesis 1010 or thesheath 1060, respectively, and/or any other components or features ofthe delivery catheter 1000 can have radiopaque markers or otherindicators to assist a medical practitioner in the deployment proceduresdescribed herein or other suitable deployment procedures.

With the branch sheaths 1024 in the target vessels and the outer sheath1006 axially retracted, as shown in FIG. 19 , a proximal portion 1010 bof the prosthesis 1010 can be deployed by axially advancing the distalsheath 1012 relative to the inner core 1020 and the prosthesis 1010. Theprosthesis 1010 can be axially and rotationally secured to the outertube 1018, which can be axially and rotationally secured to the innercore 1020, such that advancing the distal sheath 1012 relative to theinner core 1020 will advance the distal sheath 1012 relative to theprosthesis 1010. As described above, the distal sheath 1012 can beadvanced relative to the inner core 1020 and the prosthesis 1010 byadvancing the inner tube 1016 relative to the inner core 1020, the innertube 1016 being axially engaged with the distal tip 1014 which cansupport the distal sheath 1012.

FIG. 20 is a sectional view of a portion of a patient’s vasculature,showing a peelable sheath 1060 being removed from the distal portion1010 a of the prosthesis 1010 so as to deploy a distal portion 1010 a ofthe prosthesis 1010. The sheath 1060 can be removed by axiallyretracting a release wire 1062, which can be looped or other otherwisethreaded through openings or perforations 1064 formed in the sheathmaterial. The release wire 1062 can be configured to tear through thesheath material between the perforations 1064, thereby permitting theself-expanding prosthesis 1010 to expand toward the vessel walls. Asmentioned, the prosthesis 1010 can be configured to be restrained withinthe outer sheath 1006 and the distal sheath 1012 such that an additionalrestraint, such as the peelable sheath 1060, is not required.

As illustrated, a distal portion 1060 a of the sheath 1060 can be tornby the release wire 1062 before a proximal portion 1060 b of the sheath1060 is torn by the release wire so that a proximal portion 1010 b ofthe prosthesis (i.e., adjacent to the proximal portion 1060 a of thesheath 1060) can be deployed before a distal portion 1010 a of thesheath 1010. A proximal portion 1060 b or a middle portion of the sheath1060 can be torn by the release wire 1062 before a distal portion 1060 aof the sheath 1060 is torn by the release wire (not illustrated). Therelease wire 1062 can be secured to the proximal portion 1060 b or othersuitable portion of the sheath 1060 such that, after the sheath 1060 hasbeen torn, the sheath 1060 can be removed through the delivery catheter1000 by continuing to axially retract the release wire 1062 relative tothe prosthesis 1010.

As illustrated, a distal portion 1010 a of the prosthesis 1010 (i.e.,the downstream portion of the prosthesis 1010) can be deployed within anopening of an adjacent prosthesis, such as without limitation thebifurcated prosthesis 1080 illustrated in FIG. 20 . However, thedelivery catheter 1000 or any other delivery catheter described hereincan be used to deploy any suitable prosthesis, including a bifurcatedprosthesis or otherwise, in any portion of a patient’s vasculature. Assuch, the prosthesis 1010 can be a bifurcated prosthesis.

FIG. 21 is a sectional view of a portion of a patient’s vasculature,showing a fenestration alignment component 1026 contacting and pushingan inner wall of the prosthesis 1010 adjacent to a fenestration 1011toward an ostium of the target branch vessel. As illustrated, thefenestration alignment component 1026 can be advanced through a lumen inthe inner core 1020 to push the fenestration 1011 of the prosthesis 1010over the branch sheath 1024 and into approximate alignment with theostium of the branch vessel. The catheter system 1000 can be configuredto not have a fenestration alignment component 1026, and can accordinglybe configured to deploy a fenestrated graft without the use of such acomponent

As illustrated in FIG. 22 , a covered or uncovered branch stent 1084 canbe deployed in the branch vessel by advancing the branch stent 1084through the branch sheath 1024 using a suitable catheter, such as arenal stent catheter, into the target vessel, after the angiographiccatheter has been removed from the branch sheath 1024. The stent 1084can be supported on an inflation balloon 1086, which can be supported bya guidewire 1088. The guidewire 1088 can be configured to have aninflation lumen therein, to inflate the balloon 1086 and expand thebranch stent 1084 in the target location after the branch sheath 1024has been at least partially retracted so as to not interfere with theexpansion of the branch stent 1084, as illustrated in FIG. 23 . Theinflation balloon 1086 can be configured to expand and flare a portionof the stent 1084 within or to the inside of the fenestration 1011formed in the prosthesis.

The fenestration alignment component 1026 described above can beconfigured to be supported within a renal or branch stent deliverycatheter. For example, the fenestration alignment component 1026 can beconfigured to be supported within a modified renal stent catheter, suchas the renal stent catheter illustrated in FIG. 22 . The fenestrationalignment component 1026 can be configured to only partially surroundthe branch sheath 1024 or the branch stent delivery catheter. In thisconfiguration, the fenestration alignment component 1026 can beconfigured to be entirely positioned within and advanceable through alumen of the branch sheath 1024 or the branch stent delivery catheter.For example, the fenestration alignment component 1026 can have anexpandable end portion that can automatically expand when the endportion is advanced past the end of the lumen, so as to enable the endportion to snare or engage the graft material surrounding thefenestration.

Additionally, the branch stent delivery catheter can be configured tohave a snare, protrusion, or other object tethered to the balloon orstent, or to be projecting from an outside surface thereof to snare orengage the graft material adjacent to the fenestration, so as to causethe fenestration to be advanced toward the ostium as the branch stentdelivery catheter is advanced through the fenestrations. For example,the branch stent delivery catheter can have a biased wire membersupported on an outside surface of the branch stent delivery catheterthat is biased to expand when the wire member is advanced past the endof the branch sheath 1024. The wire member can expand to a size that islarger than the size of the fenestration. The wire member can besupported at a position that is offset from an end of the branch stentdelivery catheter.

The fenestration 1011 in the prosthesis 1010 can expand as the branchstent 1084 is being expanded, to improve the seal between thefenestration 1011 and the branch stent 1084. A second expansion ballooncan be positioned in the portion of the stent 1084 within or to theinside of the fenestration 1011 to flare that portion of the stent 1084,either with or without removing the first balloon used to expand themain portion of the branch stent 1084.

Some arrangements are directed to methods of deploying an endoluminalprosthesis, such as without limitation the prosthesis 1010 describedabove, comprising inserting a delivery catheter such as catheter system1000 into an artery, exposing one or more branch sheaths 1024, advancingone or more angiographic catheters having one or more guidewires intothe one or more branch sheaths 1024 and cannulating the target branchvessels, advancing the one or more branch sheaths 1024 over theangiographic catheters and into the target branch vessels, advancing thewall of the prosthesis adjacent to each of one or more fenestrations inthe prosthesis toward the ostium of the target branch vessels, removingthe one or more angiographic catheters and/or guidewires, inserting oneor more branch stents into the branch vessels, retracting the branchsheaths, expanding the branch stents, and flaring a portion of thebranch stents. In some arrangements, the target branch vessels are therenal arteries. Some arrangements also comprise deploying a proximal anddistal portion of the prosthesis. The steps of the foregoing procedurecan be performed in the sequence described, or can be performed in anysuitable sequence.

embodiments are directed to apparatuses for placing a prosthesis acrossat least one branch vessel, the prosthesis having a distal end, aproximal end, a midsection, and at least one lateral opening in themidsection of the prosthesis. The prosthesis can be constrained in adelivery system having a distal and a proximal end. The apparatus cancomprise a catheter extending from the proximal end of the deliverysystem through the lateral opening in the prosthesis, wherein aguidewire can be passed from the proximal end of the delivery systemthrough the catheter, into the branch vessel with at least the proximaland distal ends of the prosthesis remaining constrained in the deliverysystem. The prosthesis can be a stent graft.

FIGS. 24A and 24B are oblique views of a prosthesis 1200 comprising oneor more fenestrations 1202 formed in the graft 1204, and a stent orsupport member 1206. the graft 1204 is shown in dashed lines in FIG. 24Bfor clarity. The prosthesis 1200 can have any of the features,components, or other details of any other prosthesis embodimentsdisclosed herein such as, prosthesis 1010 described above. Further, anyof the features of the prosthesis 1200 can be used in combination withany of the other prosthesis embodiments disclosed herein.

The graft 1204 can be supported by the stent 1206 along at least aportion of the graft 1204. Further, the graft 1204 can be overlapped andcan have stitching or sutures 1208 along one or more edges of the graft1204, which can improve the tear resistance of the graft 1204 and canimprove the connection between the graft 1204 and the stent 1206.

Similar to other graft embodiments described herein, the graft 1204 canbe configured to have excess or slack graft material in at least aportion thereof relative to the stent which supports the graft. Forexample, the excess graft material can form a bulge or other enlargementin the graft 1204 in the approximate location of one or morefenestrations 1202 formed through the graft material. The excess orslack material along the circumference of the graft 1204 (for example,in the enlarged portion 1204 a of the graft 1204) can allow forcircumferential and/or axial movement of the graft material and, hence,the one or more fenestrations 1202, relative to the stent 1206 and theostium of the patient’s branch vessels. Therefore, the diameter of thegraft 1204 at and/or adjacent to the location of one or morefenestrations 1202 can be larger than the local diameter of the targetvessel. Similarly, the diameter of the graft 1204 at and/or adjacent tothe location of one or more fenestrations 1202 can be larger than thediameter of the non-enlarged portion of the graft material. In someembodiments, the outside surface of the graft 1204 in the enlargedportion 1204 a or otherwise can be free from any corrugations or otherpreformed folds, overlaps, or other similar pre-formed features.

Further, similar to any of the other graft embodiments disclosed herein,the graft 1204 can have excess graft material in an axial direction, inaddition to or in the alternative of the diametrically enlarged portion.The excess or slack material along the length of the graft 1204 canincrease the circumferential and/or axial adjustability or movement ofthe graft material adjacent to the one or more fenestrations 1202 formedin the graft 1204. Accordingly, the length of the graft material betweenthe proximal and distal attachment points to the stent 1206 can belonger than that of the stent 1206 between the proximal and distalattachment points. Or, the graft material in a mid-portion of the graft1204, including on either side of the enlarged portion 1204 a, can havean increased length relative to the stent radially adjacent to suchgraft portion.

Further, the enlarged portion and/or excess length of the graft 1204 orany other graft embodiment disclosed herein can be free from anyattachment points to the stent or support member which supports thegraft 1204. In these configurations, the positional adjustability of thefenestrations can be increased because the graft material is free tomove in an axial and/or circumferential direction relative to the stentand relative to the ostium of the target branch vessels. The enlargedportion and/or excess length of the graft 1204 or any other graftembodiment disclosed herein can be configured to have only a limitednumber of attachment points to the stent or support member whichsupports the graft 1204. The attachment points can be sufficiently awayfrom the fenestration or opening so as to not substantially affect theadjustability of the fenestration. For example, the prosthesis 1010 canbe configured such that the enlarged or slack portion of the graft hasonly a limited number of attachments to a stent or connector (such asconnector 1254) away from the fenestrations 1202 so that theadjustability of the enlarged or slack portion is not significantlyaffected. For example, in embodiments having only one fenestration inthe enlarged portion, the attachment or attachments to the stent orother support member can be positioned on an opposite side of the graftas compared to the position of the fenestration. In theseconfigurations, the positional adjustability of the fenestrations can beincreased because the graft material is substantially free to move in anaxial and/or circumferential direction relative to the stent andrelative to the ostium of the target branch vessels.

With reference to FIGS. 24A-25 , the graft 1204 can have one or moreenlarged portions 1204 a having an enlarged diameter relative to thetarget vessel or relative to one or more non-enlarged portions of thegraft 1204, such as portions 1204 b, 1204 c that can improve the radialand/or axial adjustability of the fenestrations 1202 formed in theenlarged portions 1204 a to better accommodate asymmetrically positionedbranch vessel ostium. In some embodiments, with reference to FIGS. 24Aand 24B, the graft 1204 can have an enlarged middle portion 1204 ahaving one or more fenestrations 1202 formed therein, a non-enlargedproximal portion 1204 b, and a non-enlarged distal portion 1204 c.

As discussed above, in the prosthesis 1200, the enlarged portion 1204 aof the graft 1204 can have a diameter that is approximately 30% largerthan a diameter of the target vessel or the diameter of the non-enlargedportions 1204 b, 1204 c of the graft 1204. The diameter of the enlargedportion 1204 a of the graft 1204 can be from approximately 20% or lessto approximately 50% or more, or from approximately 25% to approximately40% larger than the target vessel or the diameter of the non-enlargedportions 1204 b, 1204 c of the graft 1204, or to or from any valueswithin these ranges.

Additionally, the enlarged portion 1204 a or portion of the graft 1204adjacent to the enlarged portion 1204 a of the graft 1204 can be sizedand configured to be substantially longer (i.e., in the axial direction)than the stent 1206, which can improve the radial and/or axialadjustability of the fenestrations 1202 formed in the enlarged portions1204 a to better accommodate the asymmetric and/or non-uniformpositioning of branch vessel ostium. The graft 1204 can be longer thanthe stent 1206 in both the enlarged portion 1204 a of the graft 1204and/or in the portion of the non-enlarged distal portion 1204 c of thegraft adjacent to the enlarged portion 1204 a of the graft 1204. Forexample, the enlarged portion 1204 a or portion of the graft 1204adjacent to the enlarged portion 1204 a of the graft 1204 can be sizedand configured to be approximately 20% longer in the axial directionthan the stent 1206. The enlarged portion 1204 a or portion of the graft1204 adjacent to the enlarged portion 1204 a of the graft 1204 can besized and configured to be from approximately 10% to approximately 40%or more longer in the axial direction than the stent 1206.

FIG. 25 is a top view of the prosthesis 1200 of FIG. 24 . With referenceto FIGS. 24-25 , the prosthesis 1200 can have fenestrations 1202 formedin an enlarged portion 1204 a of the graft 1204. The fenestrations 1202can be formed at non-diametrically opposed positions. This can improvethe alignment of the fenestrations 1202 with the ostium of the targetbranch vessels, which in general can be located at non-diametricallyopposed positions. The fenestrations 1202 formed in either the enlargedportion or portions 1204 a or non-enlarged portions 1204 b, 1204 c ofthe graft 1204, can be angled away from the diametrically opposedposition (represented by angle X in FIG. 25 ) such that thefenestrations 1202 are separated by an angle (represented by angle Y inFIG. 25 ) that is less than 180 degrees.

For example, the graft 1204 can have two fenestrations 1202 formed at anangle away from the diametrically opposed position (represented by angleX in FIG. 25 ) of approximately 15 degrees such that the fenestrations1202 are separated by an angle (represented by angle Y in FIG. 25 ) thatis approximately 150 degrees. The graft 1204 can have two fenestrations1202 formed at an angle away from the diametrically opposed position ofbetween approximately 10 degrees or less and approximately 20 degrees ormore, such that the fenestrations 1202 are separated by an angle(represented by angle Y in FIG. 25 ) that is between approximately 160degrees and approximately 140 degrees.

The graft 1204 can have two fenestrations 1202 formed in an enlargedportion 1204 a of the graft and wherein the fenestrations 1202 areseparated by an angle that is less than 180 degrees, for exampleapproximately 150 degrees. In this configuration, positioning thefenestrations 1202 to be separated by an angle that is less than 180degrees (such as, for example, approximately 150 degrees) can improvethe alignment of the fenestrations 1202 with the ostium of the targetbranch vessels such that the enlarged portion 1204 a of the graft 1204can be from approximately 20% to approximately 60% greater than thenon-enlarged portion 1204 b, 1204 c of the graft 1204. In thisconfiguration, the enlarged portion 1204 a of the graft 1204 can be fromapproximately 20% to approximately 40% greater than the non-enlargedportion 1204 b, 1204 c of the graft 1204.

The graft 1204, which can be a bifurcated or other suitably configuredgraft, can have two fenestrations 1202 formed in an enlarged portion1204 a of the graft, wherein the fenestrations 1202 can be separated byan angle that is less than 180 degrees, and wherein the length of atleast a portion of the graft 1204 can be substantially greater than thelength of the stent 1206, for example approximately 10% greater than thelength of the stent 1206. In this configuration, positioning thefenestrations 1202 to be separated by an angle that is less than 180degrees (such as, for example, approximately 150 degrees) and increasingthe length of the graft 1204 to be approximately 10% greater than thelength of the stent 1206 can improve the alignment/alignability of thefenestrations 1202 with the ostium of the target branch vessels suchthat the enlarged portion 1204 a of the graft 1204 can be fromapproximately 10% or less to approximately 20% greater than thenon-enlarged portion 1204 b, 1204 c of the graft 1204.

With reference to FIGS. 24-25 , though not required, the prosthesis 1200can have reinforced fenestrations 1202 comprising a tubular member 1210inserted through the fenestration 1202 and stitched to the graft 1204with one or more sutures 1212. In this configuration, which will bedescribed in greater detail below, the tubular member 1210 can improvethe tear resistance of the fenestration 1202 and also improve thesealability between the fenestrations 1202 and the branch grafts andstents deployed within the fenestrations 1202 as well as the pull-outresistance of the branch grafts and stents within the fenestrations1202. This configuration can reduce leakage between the fenestrations1202 and the branch grafts and stents deployed within the fenestrations1202. In some embodiments, this configuration can also increase theforce required to pull the branch grafts and stents deployed within thefenestrations 1202 out of the fenestrations 1202, thereby reducing theinadvertent axial movement of the branch grafts and stents deployedwithin the fenestrations 1202.

With reference to FIGS. 24A and 24B, although not required, the graft1204 can have a scallop or cut-away 1230 at a proximal end portion 1204b of the graft 1204. The cut-away 1230 can be sized and configured topermit unrestricted blood flow through a branch artery, such as thesuprarenal and/or the celiac arteries. The size of the cut-away 1230 canbe based on the anatomy of a patient, or can be sized to accommodate awide range of vessel anatomies. The cut-away 1230 can have a lengthapproximately equal to the length of two stent struts, such as stentstrut 1246 described below. The graft 1204 can be overlapped and havestitching 1208 along an edge of the cut-away 1230. The prosthesis 1200can have a flared proximal end portion to increase the sealability ofsuch end portion of the prosthesis 1200.

As described above, the prosthesis 1200 can have one or more radiopaquemarkers, such as but not limited to the annular radiopaque marker 1222surrounding at least a portion of the fenestration 1202, for improvedvisibility under fluoroscopy during deployment. Any of the radiopaquemarkers can be formed from gold or platinum, or any suitable material.Any of the radiopaque markers can be formed from a suitablenon-reinforcing metallic material.

FIG. 27 is a side view of the stent 1206 shown in FIG. 24 , viewed alonga line that is perpendicular to an axis projecting through afenestration formed in the graft 1204 (not shown). For clarity, thelocation of a fenestration 1202 is shown dashed lines. FIG. 28 is a sideview of the stent 1206, viewed along an axis projecting through afenestration. Again, for clarity, the location of a fenestration 1202 isshown dashed lines.

With reference to FIGS. 26 and 27-28 , the stent 1206 can be formed fromone or more wires forming a plurality of loops 1240, which can be closedloops or eyelets, bends 1242, and struts 1246. Some of the bends 1242can be configured to slide along a portion of the length of a respectivestrut 1246, to improve the flexibility and bendability of the stent1206. The positioning of the plurality of loops 1240 and bends 1242 canbe longitudinally offset or staggered to decrease the collapsed diameterof the prosthesis 1200.

The stent 1206 can comprise a first stent segment 1250 formed from oneor more lengths of wire, a second stent segment 1252 formed from one ormore lengths of wire, and one or more connecting members 1254 formedfrom one or more lengths of wire. The first and second stent segments1250, 1252 can be positioned proximally and distally relative to thelocation of the fenestration (shown in dashed lines) that can be formedin the graft (not illustrated) that can be supported by the stent 1206.The length of the first stent segment 1250 can be sufficient to resultin an increased seal zone in the suprarenal portion of the aorta, suchas a length that extends to a position adjacent to or overlapping thesuperior mesenteric artery and/or the celiac artery.

In some embodiments, two connecting members 1254 can be positionedbetween the first and second stent segments 1250, 1252, and can be sizedand offset from one another to provide a significant gap around theposition of the fenestrations 1202 to increase the accessibility andadjustability of the fenestrations 1202 during deployment of theprosthesis 1200. As illustrated, the connecting members 1254 can havefour struts. The connecting members 1254 can have three or less struts,or can have five or more struts. The connecting members 1254 can have afirst connecting member 1254 having fewer struts than a secondconnecting member 1254.

FIGS. 29-31 are oblique, side, and end views, respectively, of afenestration alignment component 2026 (also referred to as a push memberor alignment device) that can be used in any of the delivery catheterembodiments disclosed herein. FIG. 32 is an oblique view of a deliverycatheter 2004 having the fenestration alignment component 2026 of FIG.29 . FIG. 33 is an exploded view of the delivery catheter 2004 shown inFIG. 32 . In some delivery catheter embodiments, one or morefenestration alignment components 2026 can be used in place of or inconjunction with one or more fenestration alignment components 1026described above in any of the delivery catheter embodiments disclosedherein.

Therefore, the fenestration alignment component 2026 can serve the sameor similar function or be used for the same or similar procedural stepor steps as with the embodiments of the fenestration alignment component1026 described above. Therefore, the fenestration alignment component2026 can be used in any of the procedures, steps, or methods asdescribed above for the fenestration alignment component 1026. Forexample, after the main body of a prosthesis (such as prosthesis 1010)has been released from the outer sheath 1006 and any other radialrestraints, a user can independently or collectively axially advance thefenestration alignment component 2026 relative to the guide sheath 2024(which can be the same as the guide sheath 1024 described above)supporting the fenestration alignment component 2026 such that a portionof the fenestration alignment component 2026 engages the fenestration orbranch graft of the prosthesis 1010 and pushes the fenestration orbranch graft toward an ostium of the target branch vessel of thepatient’s vasculature.

A body portion 2027 of the fenestration alignment component 2026 can beslidably positioned around or over an outside surface of the guidesheath 2024. As illustrated in FIGS. 29, 31, and 32 , the body portion2027 can be cylindrical or tubular. The body portion 2027 can have aninside diameter or size that is greater than an outside diameter or sizeof the guide sheath 1024 so that the fenestration alignment component2026 can axially translate relative to the guide sheath 1024. The bodyportion 2027 can have in inner diameter or cross-sectional size ofapproximately 0.114 in, or from approximately 0.10 in or less toapproximately 0.125 inches or more. The body portion 2027 can have inouter diameter or cross-sectional size of approximately 0.126 in, orfrom approximately 0.110 in or less to approximately 0.15 inches ormore.

The body portion 2027 can have a length of approximately 7.1 cm (2.80in), or from approximately 5 cm (1.97 in) or less to approximately 10 cm(3.94 in), or between any values within the foregoing range. The bodyportion 2027 can be formed from a PEBAX covered alloy coil. For example,the body portion 2027 can have a stainless steel coil with a PEBAX tubesurrounding the coil. The PEBAX can have varying hardness. The bodyportion 2027 can have a PTFE liner surrounding all or a portion of thebody portion 2027. Additionally, the body portion 2027 can have aradiopaque marker or band supported thereon, or have portions orcomponents thereof that are made from a radiopaque material. Forexample, a radiopaque band having a length of approximately 0.020 in toapproximately 0.060 in can be supported by the body portion 2037.

As will be described in greater detail, the fenestration alignmentcomponent 2026 can have a snare, tab, protrusion, or other similarfeature supported by the body portion to engage a portion of theprosthesis adjacent to the fenestration. For example, with reference tothe illustrated embodiments, the fenestration alignment component 2026can have a tab or protruding portion 2028 (also referred to as aprotrusion or projection) projecting from the body portion 2027. Theprotruding portion 2028 can project away from the outside surface of thebody portion 2027 by approximately 0.036 in, or from approximately 0.025in to approximately 0.050 in, or from approximately 0.030 in toapproximately 0.045 in, or between any values within any of theforegoing ranges. The protruding portion 2028 can define across-sectional size (in at least one direction) or diameter that isfrom approximately 20% or less to approximately 40% or more greater thana cross-sectional size or diameter of the body portion 2027 and/or thefenestration, or between any values within this range.

In some embodiments, the protruding portion or other component orelement supported at an end of the body portion 2027 can be inflatableor otherwise moveable between a first position and a second positionwherein, in the second position, such component or element projects awayfrom the body portion 2027 more than in the first position. For example,without limitation, the component or element can be a small inflatableballoon positioned at an end of the body portion having a hollow wire influid communication with an inner volume thereof. The positioning wire2030 could be made hollow to allow for inflation of the inflatablecomponent or element.

The protruding portion 2028 can be integrally formed with the bodyportion 2027, or can be formed separately and adhered to, supported by,or otherwise coupled with the body portion 2027. The protruding portion2028 can have a length of approximately 7 mm (0.276 in) or fromapproximately 5 mm (0.197 in) or less to approximately 10 mm (0.394 in)or more, or between any values within the foregoing range. Theprotruding portion 2028 can be made from PEBAX. The protruding portion2028 can be made from a PEBAX material having a higher hardness valuethan the PEBAX material used to form the body portion 2027.

As mentioned, the fenestration alignment component 2026 can beconfigured to engage a fenestration of a prosthesis deployable by thedelivery catheter 2004. For example, the enlarged or protruding portion2028 can have a size or profile that is greater than a size or profileof the guide sheath 2024 or of the body portion 2027 of the fenestrationalignment component 2026 so that, while the guide sheath 2024 can beadvanced through the fenestration, the protruding portion 2028 can besized and configured to be larger than the size or diameter of thefenestration so that the protruding portion 2028 does not pass throughthe fenestration.

The enlarged portion 2028 of the fenestration alignment component 2026can have a circular cross-sectional shape or, as illustrated in FIGS.29-31A, a non-circular cross-sectional shape. For example, the enlargedportion 2028 can have an approximately triangular or pointed shape witha rounded upper surface or portion 2028 a. The enlarged portion 2028 canhave a circular cross-sectional shape or a pointed shape with more thanone pointed or protruding portion, or any other suitable shape.

With reference to FIGS. 29-30 , the enlarged portion 2028 can have atapered surface 2028 b at the trailing end of the enlarged portion 2028.The tapered surface 2028 b can facilitate the removability of thefenestration alignment component 2026 if the enlarged portion 2028 ofthe fenestration alignment component 2026 is inadvertently advancedthrough a fenestration.

The fenestration alignment components 2026 can each be attached topositioning wires 2030 such that axially advancing or retracting thepositioning wires 2030 will advance or retract the fenestrationalignment components 2026. The positioning wires 2030 can each define atapering cross-sectional size that decreases toward a distal end of thepositioning wire 2030 such that a cross-sectional size of thepositioning wire 2030 near the body portion 2027 is smaller than across-sectional size of the positioning wire 2030 near the catheterhandle. The positioning wire 2030 can made from a PTFE coated stainlesssteel, such as 304, or from any other suitable material or combinationof materials. The positioning wire 2030 can have a diameter orcross-sectional size as large as approximately 0.0345 in, tapering downto a diameter or cross-sectional size of approximately 0.0200 in. Thepositioning wire 2030 can have a uniform diameter or cross-sectionalsize along the length thereof.

With reference to FIG. 31B, an end portion 2030 a of the positioningwire 2030 can overlap and be affixed to the body portion 2037 of thefenestration alignment component 2026. For example, betweenapproximately 1.0 cm (0.394 in) or less and 1.5 cm (0.591 in) or more ofthe positioning wire 2030 can overlap the body portion 2037. The endportion 2030 a can be bonded to the body portion 2037 using any suitabletechnique or process. For example, the end portion 2030 a can bethermally bonded to the body portion 2037 using one or more PET sleeves.A portion of the end portion 2030 a can be coined or flattened. The endportion can have a greater surface area than a remainder of the endportion 2030 a. For example, approximately half of the end portion 2030a can be coined or flattened.

FIG. 32 is an oblique view of a delivery catheter 2004 having thefenestration alignment component 2026 of FIG. 29 . FIG. 33 is anexploded view of the delivery catheter 2004 shown in FIG. 32 . FIG. 32illustrates a handle portion 2050 of the delivery catheter 2004, whichcan provide an entry point for the guide sheaths 2024 and thepositioning wires 2030 so as to provide an orifice or access port forthese components into the main body of the delivery catheter 2004. Inthis configuration, a surgeon or user can manipulate the guide sheaths2024 and fenestration alignment components 2026 by manipulating the endportions of the guide sheaths 2024 and positioning wires 2030 thatextend proximally from the end of the handle portion 2050 of thedelivery catheter.

The catheter 2004 can have two or more guide sheaths 2024 and two ormore fenestration alignment components 2026, or the same number of guidesheaths 2024 and fenestration alignment components 2026 as the number offenestrations in the prosthesis. The catheter 2004 having guide sheaths2024 with fenestration alignment components 2026 as described herein canbe configured such that the guide sheaths 2024, fenestration alignmentcomponents 2026, and/or positioning wires 2030 are advanceable withinstandard lumen formed in the delivery catheter 2004. The lumen of thedelivery catheter 2004 may be enlarged or sized and configured toaccommodate such guide sheaths 2024 with fenestration alignmentcomponents 2026.

FIG. 34 is a sectional view of a portion of a patient’s vasculature,showing the fenestration alignment component 2026 illustrated in FIG. 29advancing an inner wall of the prosthesis adjacent to a fenestrationtoward an ostium of the target branch vessel. As illustrated, thefenestration alignment component 2026 of the catheter 2004 can beaxially advanced relative to the guide sheath 2024 (which can be thesame as any other guide sheath embodiments disclosed herein, includingwithout limitation guide sheath 1024) by advancing the positioning wire2030 distally to push the fenestration 1011 of the prosthesis 1010 overthe branch sheath 2024 and into approximate alignment with the ostium ofthe branch vessel. The catheter system 2004 can be configured to nothave a fenestration alignment component 2026, and can accordingly beconfigured to deploy a fenestrated graft without the use of such acomponent. As will be described below, snares, protrusions, tabs, orother features can be formed on the sheaths 1024 to push thefenestrations toward the branch vessel ostium.

FIG. 35 is a sectional view of a portion of a patient’s vasculature,showing a branch stent being advanced into the target branch vesselwhile the fenestration alignment component 2026 can be used to maintainthe inner wall of the prosthesis adjacent to a fenestration in theprosthesis in the desired position relative to the ostium of the targetbranch vessel. As illustrated in FIG. 35 , the fenestration alignmentcomponents 2026 have been advanced to a second position, the secondposition being defined as the position where the fenestrations 1011 areapproximately aligned with the ostium of the target branch vessels. Asillustrated in FIG. 35 , a covered or uncovered branch stent 1084 can bedeployed in the branch vessel by advancing the branch stent 1084 throughthe branch sheath 2024 using a suitable catheter, such as a renal stentcatheter, into the target vessel, after the angiographic catheter hasbeen removed from the branch sheath 2024.

The stent 1084 can be supported on an inflation balloon 1086, which canbe supported by a guidewire 1088. The guidewire 1088 can be configuredto have an inflation lumen therein, to inflate the balloon 1086 andexpand the branch stent 1084 in the target location after the branchsheath 2024 has been at least partially retracted so as to not interferewith the expansion of the branch stent 1084. The fenestration alignmentcomponents 2026 may need to be at least partially withdrawn beforedeploying the stents 1084, to enable the inflation balloon to expand thestents 1084. The inflation balloon 1086 can be configured to expand andflare a portion of the stent 1084 within or to the inside of thefenestration 1011 formed in the prosthesis. Thereafter, the componentscomprising the delivery catheter 2004 can be withdrawn, and/oradditional prostheses can be deployed in the patient’s vasculature,including without limitation a suprarenal stent graft, or other desiredcomponents.

As mentioned, any embodiments of the delivery catheter 2004 can have anyof the same features, materials, components, dimensions, or otherdetails of any other catheter disclosed herein, including withoutlimitation the embodiment(s) of the delivery catheter 1004 describedabove. Like numbered features shown in the illustrations of the deliverycatheter 2004 can be the same or similar to the same numbered featuresof the delivery catheter 1004 embodiments described herein.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the device or process illustrated can be madewithout departing from the spirit of the disclosure. Additionally, thevarious features and processes described above can be used independentlyof one another, or can be combined in various ways. All possiblecombinations and sub combinations are intended to fall within the scopeof this disclosure.

As will be recognized, certain embodiments described herein can beembodied within a form that does not provide all of the features andbenefits set forth herein, as some features can be used or practicedseparately from others. Unless otherwise defined herein, the termapproximate or approximately means values within 10% of the statedvalue.

Additionally, any embodiments of the fenestration alignment componentsor devices disclosed herein can be used to deploy any suitablefenestrated prosthesis, with or without modification within the scope ofone of ordinary skill in the art. For example and any embodiments of thefenestration alignment components or devices disclosed by the referencespreviously incorporated by reference in their entireties as if fully setforth herein. All such embodiments and combinations of embodiments arehereby incorporated by reference as if fully set forth herein. Further,any embodiments of the fenestration alignment components or devicesdisclosed herein can be used in combination with any of the deliverydevices disclosed in either of the foregoing applications, and suchcombinations are hereby incorporated by reference as if fully set forthherein.

1-20. (canceled)
 21. A fenestrated graft deployment system, comprising:a catheter body; and a first fenestration alignment device extendingthrough at least a portion of the catheter body, the first fenestrationalignment device configured to be axially moveable between a firstposition and a second position, the first fenestration alignment devicebeing prepositioned within the delivery catheter when the deliverycatheter is in a predeployment state; wherein the first fenestrationalignment device comprises a tubular shaped member and a protrusionprojecting from an outside surface of a distal portion of the tubularshaped member, the protrusion comprising a non-circular cross-sectionalshape and being sized and configured to engage a lateral opening of anendoluminal prosthesis when the first fenestration alignment device isadvanced toward the second position.
 22. The fenestrated graftdeployment system of claim 21, further comprising a first guidewireprepositioned within the delivery catheter when the delivery catheter isin the predeployment state.
 23. The fenestrated graft deployment systemof claim 22, wherein the first fenestration alignment device isconfigured to be axially moveable along the first guidewire between thefirst position and the second position.
 24. The fenestrated graftdeployment system of claim 22, wherein the distal end portion of thetubular shaped member comprises a wall portion that surrounds at least aportion of the first guidewire.
 25. The fenestrated graft deploymentsystem of claim 22, wherein the first guidewire is a hollow guidewire orhollow sheath.
 26. The fenestrated graft deployment system of claim 22,wherein a distal end portion of the first guidewire is within a lumen ofthe catheter body when the first guidewire is prepositioned within thedelivery catheter.
 27. The fenestrated graft deployment system of claim21, wherein the first fenestration alignment device is configured toapproximately align the lateral opening of the endoluminal prosthesiswith an ostium of the first target branch vessel when the firstfenestration alignment device is advanced to the second position. 28.The fenestrated graft deployment system of claim 21, further comprisinga second fenestration alignment device.
 29. The fenestrated graftdeployment system of claim 21, wherein in the predeployment state, anend portion of the first fenestration alignment device is configured tobe positioned within a lumen of the endoluminal prosthesis.
 30. Thefenestrated graft deployment system of claim 21, further comprising aninner core at least partially extending through the catheter body. 31.The fenestrated graft deployment system of claim 30, wherein in thepredeployment state, an end portion of the first fenestration alignmentdevice is positioned distal to the inner core.
 32. The fenestrated graftdeployment system of claim 21, wherein the protrusion comprises atapered surface.
 33. The fenestrated graft deployment system of claim21, further comprising the endoluminal prosthesis.